Process Development Sr. Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock‑based long‑term incentives

Award‑winning time‑off plans

Flexible work models

Job summary

Amgen in Thousand Oaks is seeking a Process Development Senior Scientist to lead analytical development for diverse early-stage protein therapeutics, guiding method development, quality attributes, and regulatory readiness across multiple programs.

You will design experiments, apply HPLC/UPLC, CE and mass spectrometry to characterize products, collaborate with cross-functional teams, author regulatory documents, and propel projects toward pivotal milestones within strict timelines.

Qualifications

• PhD, PharmD, or MD with relevant post‑doc experience.
• Masters degree and 3 years of directly related life science experience
• Bachelors degree and 5 years of directly related life science experience

Responsibilities

• Serves as the Attribute Sciences representative on cross-functional project teams.
• Designs experiments to understand protein attributes and stability.
• Applies analytical methods to characterize protein therapeutics (CE, SEC, IEX, RP, HILIC, MS).
• Evaluates analytical method performance and changes.
• Supports drug substance and drug product process development and regulatory submissions.
• Authors regulatory documents and supports regulatory expectations for methods and control strategies.
• Stays current in the field and evaluates emerging analytical technologies.

Skills

Analytical leadership

Experimental design

Data interpretation

Cross-functional collaboration

Scientific writing

Education

PhD / PharmD / MD or equivalent

Tools

HPLC/UPLC

CE

Mass spectrometry

IEX

RP

HILIC

Job description

Process Development Senior Scientist

What You Will Do

Lets do this. Lets change the world. In this vital role you will support Amgen's diverse early-stage therapeutic portfolio by characterizing process and product properties of large-molecule drug candidates and assessing quality attributes of protein therapeutics across multiple pipeline areas. This role will provide analytical leadership for pre-pivotal programs and apply advanced analytical techniques to characterize novel modalities in development.

• Serves effectively as the Attribute Sciences representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.
• Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.
• Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.
• Evaluates analytical method performance and reliability, including the impact of proposed method changes.
• Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.
• Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.
• Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.
• Stays current in the field and evaluates emerging analytical technologies.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable]

OR

Masters degree and 3 years of directly related life science experience

OR

Bachelors degree and 5 years of directly related life science experience

Preferred Qualifications

• Ph.D. in analytical chemistry, biochemistry, biophysics, or a related life science field, with 2 years of industry experience.
• Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics.
• Proven experience in separation sciences, protein chemistry, and/or mass spectrometry.
• Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.
• Familiarity with common therapeutic protein quality attributes, such as fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their characterization and quantification.
• Understanding of, or experience with, GMP compliance.
• Ability to work independently to advance projects and studies within required timelines.
• Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast‑paced, multidisciplinary environment.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

The Amgen team invites you to apply.

careers.amgen.com

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity Employer

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.